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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02928783
Other study ID # CG13107
Secondary ID
Status Completed
Phase N/A
First received September 4, 2016
Last updated October 6, 2016
Start date June 2013
Est. completion date March 2014

Study information

Verified date October 2016
Source Taichung Veterans General Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Home-based rehabilitation programs have not been widely few been studied and the training effects are not unclear. This study evaluates the beneficial effects of home-based cardiac rehabilitation on quality of medical care in patients with chronic heart failure.


Description:

cardiopulmonary rehabilitation programs are safe and effective for improving functional capacity, quality of life, as well as for reducing in the re-admission rate and all-cause mortality of patients with heart failure.clinical trials that have established the benefits of hospital-based cardiac rehabilitation for patients with chronic heart failure. Home-based cardiac rehabilitation could be more accessible and acceptable compared with hospital-based cardiac rehabilitation.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria:

- Heart failure patients with NYHA I, II, III, and LVEF<50%.

Exclusion Criteria:

- Heart failure patients with NYHA I, II, III, and LVEF<50%. But excluded pregnancy, disability.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
Home-based cardiac rehabilitation


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Taichung Veterans General Hospital

References & Publications (6)

Haykowsky MJ, Liang Y, Pechter D, Jones LW, McAlister FA, Clark AM. A meta-analysis of the effect of exercise training on left ventricular remodeling in heart failure patients: the benefit depends on the type of training performed. J Am Coll Cardiol. 2007 — View Citation

O'Connor CM, Whellan DJ, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Miller NH, Fleg JL, Schulman KA, McKelvie RS, Zannad F, Piña IL; HF-ACTION Investigators. Efficacy and safety of exercise traini — View Citation

Schmidt C, Theilmeier G, Van Aken H, Korsmeier P, Wirtz SP, Berendes E, Hoffmeier A, Meissner A. Comparison of electrical velocimetry and transoesophageal Doppler echocardiography for measuring stroke volume and cardiac output. Br J Anaesth. 2005 Nov;95(5 — View Citation

Smart NA, Steele M. A comparison of 16 weeks of continuous vs intermittent exercise training in chronic heart failure patients. Congest Heart Fail. 2012 Jul-Aug;18(4):205-11. doi: 10.1111/j.1751-7133.2011.00274.x. Epub 2011 Nov 27. — View Citation

Suttner S, Schöllhorn T, Boldt J, Mayer J, Röhm KD, Lang K, Piper SN. Noninvasive assessment of cardiac output using thoracic electrical bioimpedance in hemodynamically stable and unstable patients after cardiac surgery: a comparison with pulmonary artery — View Citation

Tomczak CR, Thompson RB, Paterson I, Schulte F, Cheng-Baron J, Haennel RG, Haykowsky MJ. Effect of acute high-intensity interval exercise on postexercise biventricular function in mild heart failure. J Appl Physiol (1985). 2011 Feb;110(2):398-406. doi: 10 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline peak oxygen uptake (ml /kg/min) at 3 months All participants the assessment of cardiopulmonary exercise test at baseline and after completing an 3 months training programs. 3 months No
Primary Change from Baseline quality of life at 3 months All participants the assessment of Minnesota Living With HF Questionnaire (MLHFQ) at baseline and after completing an 3 months training programs. 3 months No
Primary Change from Baseline 6-min walking distance (6MWD) at 3 months All participants the assessment of 6-min walk test at baseline and after completing an 3 months training programs. 3 months No
Secondary readmission rate All participants the assessment of 90-day readmission rate after completing an 3 months training programs. 90 days No